MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. ADD-EASE BAG-TO-VIAL SYSTEM; SET, I.V. FLUID TRANSFER

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Last week my infection control rn called me to report that she was making rounds and noted that she saw several bbraun piggybacks (50 ml or 100 ml) which were hanging on the iv pump which had been spiked though the foil port seal.Coincidently i was scheduled to present my medication safety lecture at nursing orientation the next day, so i updated my presentation to include information on proper spiking of bbraun piggybacks (remove the foil seal) and activation of bbraun's add-ease bag-to-vial system.I received a comment from one of our new nurses in the audience who stated that "spiking iv bags through the foil seal was common practice" in her experience.Perhaps you are already aware of this issue, but i don't recall seeing a newsletter article.Communication, poor / lacking (nonspecific) established procedure / protocol not followed.Circumstances or events have capacity to cause error.(b)(6).Submission id: (b)(4).

• Brand Name: ADD-EASE BAG-TO-VIAL SYSTEM
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 12916146
• MDR Text Key: 281833453
• Report Number: MW5105698
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2021
• Patient Sequence Number: 1